FDAClass IIDecember 25, 2019

Roche Homocysteine-In vitro test for the quantitative recall

Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems…

Why was Roche Homocysteine-In vitro test for the quantitative recalled?

Homocysteine Reagent, Calibration Failures and Quality Control Recovery Issues on cobas c 701 and 702 modules

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Number: 422313 Exp Date: 07/31/2020

Product
Roche Homocysteine-In vitro test for the quantitative determination of total L-homocysteine in human serum and plasma on Roche/Hitachi cobas c systems…
Recalling firm
Roche Diagnostics Operations, Inc.
Quantity
82 units (US)
Distribution
US Nationwide distribution in the states of NJ, HI, IA.
Recall date
December 25, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls